Bulk Manufacturer of Controlled Substances Application: Benuvia Operations, LLC, 71927-71928 [2024-19795]
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71927
Federal Register / Vol. 89, No. 171 / Wednesday, September 4, 2024 / Notices
the online instructions at that site for
submitting comments. Upon submission
of your comment, you will receive a
Comment Tracking Number. Please be
aware that submitted comments are not
instantaneously available for public
view on https://www.regulations.gov. If
you have received a Comment Tracking
Number, your comment has been
successfully submitted and there is no
need to resubmit the same comment.
In
accordance with 21 CFR 1301.33(a), this
SUPPLEMENTARY INFORMATION:
is notice that on July 16, 2024, 256 West
Cummings Park, Woburn,
Massachusetts 01801, applied to be
registered as a bulk manufacturer of the
following basic class(es) of controlled
substance(s):
Controlled substance
Drug code
Fentanyl .........................................................................................................................................................................
The company plans to bulk
manufacture the listed controlled
substances for research and
development purposes only. No other
activity for this drug code is authorized
for this registration.
Marsha L. Ikner,
Acting Deputy Assistant Administrator.
[FR Doc. 2024–19756 Filed 9–3–24; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–1414]
Importer of Controlled Substances
Application: Catalent CTS, LLC
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
Catalent CTS, LLC has
applied to be registered as an importer
of basic class(es) of controlled
SUMMARY:
substance(s). Refer to Supplementary
Information listed below for further
drug information.
DATES: Registered bulk manufacturers of
the affected basic class(es), and
applicants, therefore, may submit
electronic comments on or objections to
the issuance of the proposed registration
on or before October 4, 2024. Such
persons may also file a written request
for a hearing on the application on or
before October 4, 2024.
ADDRESSES: The Drug Enforcement
Administration requires that all
comments be submitted electronically
through the Federal eRulemaking Portal,
which provides the ability to type short
comments directly into the comment
field on the web page or attach a file for
lengthier comments. Please go to
https://www.regulations.gov and follow
the online instructions at that site for
submitting comments. Upon submission
of your comment, you will receive a
Comment Tracking Number. Please be
aware that submitted comments are not
instantaneously available for public
In
accordance with 21 CFR 1301.34(a), this
is notice that on June 27, 2024, Catalent
CTS, LLC, 10245 Hickman Mills Drive,
Kansas City, Missouri 64137–1418,
applied to be registered as an importer
of the following basic class(es) of
controlled substance(s):
Drug code
ddrumheller on DSK120RN23PROD with NOTICES1
approved finished dosage forms for
commercial sale.
Marsha L. Ikner,
Acting Deputy Assistant Administrator.
[FR Doc. 2024–19776 Filed 9–3–24; 8:45 am]
BILLING CODE P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–1408]
Bulk Manufacturer of Controlled
Substances Application: Benuvia
Operations, LLC
Drug Enforcement
Administration, Justice.
AGENCY:
21:26 Sep 03, 2024
Jkt 262001
PO 00000
Frm 00050
Fmt 4703
Sfmt 4703
II
SUPPLEMENTARY INFORMATION:
Gamma Hydroxybutyric Acid .....................................................................................................................................
Marihuana Extract .....................................................................................................................................................
Marihuana .................................................................................................................................................................
Tetrahydrocannabinols ..............................................................................................................................................
VerDate Sep<11>2014
9801
view on https://www.regulations.gov. If
you have received a Comment Tracking
Number, your comment has been
successfully submitted and there is no
need to resubmit the same comment. All
requests for a hearing must be sent to:
(1) Drug Enforcement Administration,
Attn: Hearing Clerk/OALJ, 8701
Morrissette Drive, Springfield, Virginia
22152; and (2) Drug Enforcement
Administration, Attn: DEA Federal
Register Representative/DPW, 8701
Morrissette Drive, Springfield, Virginia
22152. All requests for a hearing should
also be sent to: Drug Enforcement
Administration, Attn: Administrator,
8701 Morrissette Drive, Springfield,
Virginia 22152.
Controlled substance
The company plans to import the
listed controlled substances as dosage
unit products for clinical trials and
distribution. In reference to drug codes
7370 Tetrahydrocannabinols, the
company plans to import a synthetic
tetrahydrocannabinol. No other
activities for these drug codes are
authorized for this registration.
Approval of permit applications will
occur only when the registrant’s
business activity is consistent with what
is authorized under 21 U.S.C. 952(a)(2).
Authorization will not extend to the
import of Food and Drug
Administration-approved or non-
Schedule
ACTION:
2010
7350
7360
7370
Schedule
I
I
I
I
Notice of application.
Benuvia Operations, LLC has
applied to be registered as a bulk
manufacturer of basic class(es) of
controlled substance(s). Refer to
Supplementary Information listed below
for further drug information.
DATES: Registered bulk manufacturers of
the affected basic class(es), and
applicants, therefore, may submit
electronic comments on or objections to
the issuance of the proposed registration
on or before November 4, 2024. Such
persons may also file a written request
for a hearing on the application on or
before November 4, 2024.
SUMMARY:
The Drug Enforcement
Administration requires that all
ADDRESSES:
E:\FR\FM\04SEN1.SGM
04SEN1
71928
Federal Register / Vol. 89, No. 171 / Wednesday, September 4, 2024 / Notices
comments be submitted electronically
through the Federal eRulemaking Portal,
which provides the ability to type short
comments directly into the comment
field on the web page or attach a file for
lengthier comments. Please go to
https://www.regulations.gov and follow
the online instructions at that site for
submitting comments. Upon submission
of your comment, you will receive a
Comment Tracking Number. Please be
aware that submitted comments are not
instantaneously available for public
view on https://www.regulations.gov. If
you have received a Comment Tracking
Number, your comment has been
successfully submitted and there is no
need to resubmit the same comment.
Controlled substance
Drug code
Ibogaine ......................................................................................
Marihuana Extract ......................................................................
Tetrahydrocannabinols ...............................................................
Mescaline ....................................................................................
3,4-Methylenedioxyamphetamine ...............................................
3,4-Methylenedioxymethamphetamine .......................................
5-Methoxy-N-N-dimethyltryptamine ............................................
Dimethyltryptamine .....................................................................
Psilocybin ....................................................................................
Psilocyn ......................................................................................
5-Methoxy-N,N-diisopropyltryptamine ........................................
The company plans to bulk
manufacture the listed controlled
substances for internal research and
dosage formulation development. No
other activities for these drug codes are
authorized for this registration.
Marsha L. Ikner,
Acting Deputy Assistant Administrator.
[FR Doc. 2024–19795 Filed 9–3–24; 8:45 am]
BILLING CODE P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–1392]
Importer of Controlled Substances
Application: Indivior Inc.
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
Indivior Inc. has applied to be
registered as an importer of basic
class(es) of controlled substance(s).
Refer to Supplementary Information
listed below for further drug
information.
DATES: Registered bulk manufacturers of
the affected basic class(es), and
applicants, therefore, may submit
electronic comments on or objections to
the issuance of the proposed registration
on or before October 4, 2024. Such
persons may also file a written request
for a hearing on the application on or
before October 4, 2024.
ADDRESSES: The Drug Enforcement
Administration requires that all
comments be submitted electronically
through the Federal eRulemaking Portal,
which provides the ability to type short
ddrumheller on DSK120RN23PROD with NOTICES1
SUMMARY:
VerDate Sep<11>2014
21:26 Sep 03, 2024
Jkt 262001
In
accordance with 21 CFR 1301.33(a), this
is notice that on June 7, 2024, Benuvia
Operations, LLC, 3950 North Mays
Street, Round Rock, Texas 78665,
applied to be registered as a bulk
manufacturer of the following basic
class(es) of controlled substance(s):
SUPPLEMENTARY INFORMATION:
Schedule
7260
7350
7370
7381
7400
7405
7431
7435
7437
7438
7439
I
I
I
I
I
I
I
I
I
I
I
comments directly into the comment
field on the web page or attach a file for
lengthier comments. Please go to
https://www.regulations.gov and follow
the online instructions at that site for
submitting comments. Upon submission
of your comment, you will receive a
Comment Tracking Number. Please be
aware that submitted comments are not
instantaneously available for public
view on https://www.regulations.gov. If
you have received a Comment Tracking
Number, your comment has been
successfully submitted and there is no
need to resubmit the same comment. All
requests for a hearing must be sent to:
(1) Drug Enforcement Administration,
Attn: Hearing Clerk/OALJ, 8701
Morrissette Drive, Springfield, Virginia
22152; and (2) Drug Enforcement
Administration, Attn: DEA Federal
Register Representative/DPW, 8701
Morrissette Drive, Springfield, Virginia
22152. All requests for a hearing should
also be sent to: Drug Enforcement
Administration, Attn: Administrator,
8701 Morrissette Drive, Springfield,
Virginia 22152.
SUPPLEMENTARY INFORMATION: In
accordance with 21 CFR 1301.34(a), this
is notice that on June 17, 2024, Indivior
Inc., 2607 Midpoint Drive, Fort Collins,
Colorado 80525–4427, applied to be
registered as an importer of the
following basic class(es) of controlled
substance(s):
Controlled
substance
Drug code
Thebaine .........
9333
Schedule
II
The company plans to import the
listed controlled substance in limited
quantity for research, clinical trials,
PO 00000
Frm 00051
Fmt 4703
Sfmt 4703
analytical purposes, and for the
manufacturing process development of
the dosage form. No other activity for
this drug code is authorized for this
registration.
Approval of permit applications will
occur only when the registrant’s
business activity is consistent with what
is authorized under 21 U.S.C. 952(a)(2).
Authorization will not extend to the
import of Food and Drug
Administration-approved or nonapproved finished dosage forms for
commercial sale.
Marsha L. Ikner,
Acting Deputy Assistant Administrator.
[FR Doc. 2024–19754 Filed 9–3–24; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–1409]
Importer of Controlled Substances
Application: Amneal Complex
Products Research LLC
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
Amneal Complex Products
Research LLC has applied to be
registered as an importer of basic
class(es) of controlled substance(s).
Refer to Supplementary Information
listed below for further drug
information.
DATES: Registered bulk manufacturers of
the affected basic class(es), and
applicants, therefore, may submit
electronic comments on or objections to
SUMMARY:
E:\FR\FM\04SEN1.SGM
04SEN1
]]>Agencies
[Federal Register Volume 89, Number 171 (Wednesday, September 4, 2024)]
[Notices]
[Pages 71927-71928]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-19795]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-1408]
Bulk Manufacturer of Controlled Substances Application: Benuvia
Operations, LLC
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
-----------------------------------------------------------------------
SUMMARY: Benuvia Operations, LLC has applied to be registered as a bulk
manufacturer of basic class(es) of controlled substance(s). Refer to
Supplementary Information listed below for further drug information.
DATES: Registered bulk manufacturers of the affected basic class(es),
and applicants, therefore, may submit electronic comments on or
objections to the issuance of the proposed registration on or before
November 4, 2024. Such persons may also file a written request for a
hearing on the application on or before November 4, 2024.
ADDRESSES: The Drug Enforcement Administration requires that all
[[Page 71928]]
comments be submitted electronically through the Federal eRulemaking
Portal, which provides the ability to type short comments directly into
the comment field on the web page or attach a file for lengthier
comments. Please go to https://www.regulations.gov and follow the
online instructions at that site for submitting comments. Upon
submission of your comment, you will receive a Comment Tracking Number.
Please be aware that submitted comments are not instantaneously
available for public view on https://www.regulations.gov. If you have
received a Comment Tracking Number, your comment has been successfully
submitted and there is no need to resubmit the same comment.
SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.33(a), this
is notice that on June 7, 2024, Benuvia Operations, LLC, 3950 North
Mays Street, Round Rock, Texas 78665, applied to be registered as a
bulk manufacturer of the following basic class(es) of controlled
substance(s):
------------------------------------------------------------------------
Controlled substance Drug code Schedule
------------------------------------------------------------------------
Ibogaine.......................... 7260 I
Marihuana Extract................. 7350 I
Tetrahydrocannabinols............. 7370 I
Mescaline......................... 7381 I
3,4-Methylenedioxyamphetamine..... 7400 I
3,4-Methylenedioxymethamphetamine. 7405 I
5-Methoxy-N-N-dimethyltryptamine.. 7431 I
Dimethyltryptamine................ 7435 I
Psilocybin........................ 7437 I
Psilocyn.......................... 7438 I
5-Methoxy-N,N- 7439 I
diisopropyltryptamine.
------------------------------------------------------------------------
The company plans to bulk manufacture the listed controlled
substances for internal research and dosage formulation development. No
other activities for these drug codes are authorized for this
registration.
Marsha L. Ikner,
Acting Deputy Assistant Administrator.
[FR Doc. 2024-19795 Filed 9-3-24; 8:45 am]
BILLING CODE P
